This Part of YY/T 0616 specifies the requirements for the biological safety evaluation of medical gloves for single use, and gives the requirements for the labeling and disclosure of information for the test methods used. This Part applies to the biological safety evaluation of medical gloves for single use.
Basic Data
Standard ID
YY/T 0616.1-2016 (YY/T0616.1-2016)
Description (Translated English)
Medical gloves for single use - Part 1: Requirements and testing for biological evaluation
Sector / Industry
Medical Device and Pharmaceutical Industry Standard (Recommended)
China Food and Drug Administration Bulletin 2016 No.25
Issuing agency(ies)
State Food and Drug Administration
Summary
This standard specifies the requirements for the use of medical gloves for biologic safety evaluation at one time, and gives the information required for labeling and published test methods. This standard applies to the use of medical gloves biology safety evaluation.
